Move over, Johnson & Johnson's (NYSE:JNJ) Risperdal and Bristol-Myers Squibb's (NYSE:BMY) Abilify! There are some new kids in town -- and they want to play with your friends.
Yesterday, a Food and Drug Administration advisory panel agreed that AstraZeneca's (NYSE:AZN) Seroquel was effective and safe enough to be used in kids diagnosed with schizophrenia or bipolar disorder, and that Pfizer's (NYSE:PFE) Geodon could be used to treat kids with the latter condition. The panel also gave the nod to Eli Lilly's (NYSE:LLY) Zyprexa to treat both indications, but only after other drugs have been tried, since its side effects include weight gain.
The FDA doesn't have to follow the panel's recommendation, but since the drugs are already approved to treat adults, it seems likely that the agency will follow its panel's advice. The FDA may require the companies to establish a Risk Evaluation and Mitigation Strategy to ensure that doctors only prescribe the drug to the right patients, but that's a minor issue.
Antipsychotics are big business. Even without being able to market their drugs to kids -- although some young patients probably take the drugs off-label -- AstraZeneca has managed to sell $4.4 billion worth of Seroquel, while Lilly's Zyprexa sales have reached nearly $4.7 billion.
The companies don't break out off-label sales to minors, but according to pharmacy benefit manager Medco Health Solutions (NYSE:MHS), sales of antipsychotics to patients younger than 19 have more than doubled since 2001. Approvals for Pfizer, AstraZeneca, and Eli Lilly should help them grab more of that market -- or, at the very least, keep their sales reps out of trouble for pushing the drugs for indications for which they're not FDA-approved.
An Rx for further Foolishness:
- The recession is (almost) over! Now what?
- Up 58% on no news? What's going on?
- It's finally time to buy these stocks.
